PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-95
SponsorLimFlow, Inc.
About this trial
A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject must be ≥ 18 and ≤ 95 years of age
Clinical diagnosis of chronic limb-threatening ischemia, defined as any of the following clinical assessments: previous angiogram or hemodynamic evidence of severely diminished arterial inflow of the index limb (e.g., ABI ≤ 0.39, TP / TcPO2 < 30 mm Hg) and
Rutherford Classification 5, ischemic ulceration or
Rutherford Classification 6, ischemic gangrene
Disqualifiers
Concomitant hepatic insufficiency, thrombophlebitis in the target limb, or non-treatable coagulation disorder within the past 90 days.
Active immunodeficiency disorder or currently receiving immunosuppressant therapy for an immunodeficiency disorder.
Prior peripheral arterial bypass procedure above or below the knee which would inhibit proximal inflow to the stent graft.
Absence of adequate viable tissue in target foot.
Trial design
Design model
Single group
Treatments tested in this trial
LimFlow Stent Graft System
DeviceCreation of an arteriovenous fistula in the desired limb location
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Treated with LimFlowExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Amputation Free Survival
Freedom from major (above-ankle) amputation and death (all-cause mortality)
Time frame
6 MonthsSecondary outcomes
1
Primary Patency
Absence of occlusion of the endovascular intervention that is maintained without the need for additional or secondary surgical or endovascular procedures
Time frame
30 Days2
Primary Patency
Absence of occlusion of the endovascular intervention that is maintained without the need for additional or secondary surgical or endovascular procedures
Time frame
6 Months3
Primary Assisted Patency
Absence of occlusion of the endovascular intervention maintained with the use of additional or secondary surgical or endovascular procedures, as long as occlusion of the primary treated site has not occurred
Time frame
30 Days4
Primary Assisted Patency
Absence of occlusion of the endovascular intervention maintained with the use of additional or secondary surgical or endovascular procedures, as long as occlusion of the primary treated site has not occurred
Time frame
6 MonthsSponsors and contacts
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Source ClinicalTrials.gov